MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Embolism (1829); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports from the distributor.Patient developed ami one week after surgery.A cather thrombectomy was performed and the embolism was removed.The surgeon asked for the explanted sample to be evaluated by the manufacturer for identification.The patient status is stable.According to the review, it was determined that the specimen was histologically consistent with bioglue.

Manufacturer Narrative

Notification of an event was received september 8, 2020 according to initial reports, a surgeon used bioglue for an acute dissection case in september and one week later the patient experienced acute myocardial infarction.The surgeon performed a catheterization and requested cryolife perform an evaluation of the material removed from the patient to confirm if it is bioglue.The patient is stable.A review of manufacturing records could not be performed as a definitive lot number was not provided by the complainant.Pieces of the explanted material were returned to cryolife for evaluation.A review of the two returned specimens was performed.The following gross description was provided.Received are two vials.The larger vial is transparent, sealed with tape, and contains a clear liquid within which is suspended a tan particle approximately 0.2 cm in greatest dimension.The smaller vial is of cloudy translucent plastic, is capped, and the cap held by adhesive tape.Within the small vial is no liquid but a dry particle of material that has an internal slight curve and a length of slightly over 0.2 cm.The particles are placed on individual pre-cut blue paper wraps for surgical biopsies.The particle from the larger vial is placed in embedding cassette a, and the particle from the smaller vial placed in cassette b.The following microscopic description was provided.Histologic sections of specimen a show predominately a homogeneous eosinophilic material with extensive sectioning (venetian blinds) artifact.Nucleated cells are adherent to the periphery of the material.However, the material proper is acellular.Sections of specimen b show similar eosinophilic material with sectioning artifact.Only rare nucleated cells are identified.The material is morphologically consistent with bioglue.The following conclusion was provided; specimen a: material histologically consistent with bioglue.Specimen b: material histologically consistent with bioglue.A review of the available information was performed.According to initial reports, the patient developed ami one week after acute aortic repair surgery where bioglue was applied to the false lumen proximal end."the cather thrombectomy was performed urgently and removed the brown material, the patient status is stable." a piece of the material was sent to cryolife to determine if it is bioglue surgical adhesive.The following information about the reported event is unknown: if negative pressure was avoided during application and polymerization, how much bioglue was used, if the false lumen was overfilled, and whether the coronary arteries were protected during the procedure.Two vials containing tan material were sent to cryolife for examination.It was determined that specimen a & b were material histologically consistent with bioglue.There are journal articles that recommend the placement of catheters in the coronary artery to protect it from obstruction.Bhamidipati et al states "similarly, a moist sponge can be used to protect the aortic valve leaflets and the coronary ostia when bioglue is being used to reconstruct a dissected aortic root.The left main coronary artery can also be protected by the gentle insertion of a red-rubber catheter to occlude the ostium".Raanani et al mentioned "it is essential to protect the ostia of the coronary arteries from accidental spillage of glue.This can be accomplished by inserting a fine flexible plastic cannula into the ostia before applying the glue".While the product ifu references using a catheter in the true lumen to keep the shape of the vessel for an aortic dissection procedure, it is not made clear to do the same for the coronary arteries : "the dissected layers of the aorta should be closely approximated by inserting a dilator, sponge, or catheter into the true lumen to preserve the natural architecture of the vessel".There is insufficient information available to determine a definitive root cause for the reported event.However, obstruction of the coronary artery caused by bioglue tracking along a false lumen extending into the coronary artery or embolization into the coronary true lumen remains a possibility.Based on the available information, a definitive root cause for this event cannot be determined.There is no indication that an error or deficiency occurred at cryolife.No further action is required.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10607206
• MDR Text Key: 209194057
• Report Number: 1063481-2020-00023
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/08/2020
• Date Manufacturer Received: 09/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention